Ad hoc announcement pursuant to Art. 53
LR: Molecular Partners AG (SIX: MOLN; NASDAQ:
MOLN), a clinical-stage biopharmaceutical company developing a new
class of custom-built protein drugs known as
DARPin therapeutics ("Molecular Partners" or the "Company"),
today announced corporate highlights and unaudited financial
results for the first half-year of 2023.
“Throughout the first half of the year, our team has worked
tirelessly to advance both our clinical programs and our platform,
and I am extremely proud of what they have accomplished. We
delivered compelling Phase 1 clinical data of MP0317 in patients
with a range of different advanced solid tumors, initiated the
first-in-human clinical trial of MP0533, a tetraspecific T cell
engager DARPin candidate for the treatment of AML, and deepened the
evidence base for the Radio DARPin Therapy platform,” said Patrick
Amstutz, Ph.D., Molecular Partners’ Chief Executive Officer. “We
are well-capitalized to advance these programs and continue
leveraging our fundamental DARPin expertise to enter new areas with
unique DARPin-based therapeutic approaches. I look forward to the
second half of the year and beyond as we turn our attention toward
MP0533, poised to generate clinical data which may represent a
profound opportunity for patients suffering from AML, both
initially in this relapsed setting, but also in combination and
potentially as front line therapy in the future."
Research & Development Highlights
Oncology
MP0533
In January 2023, the first patient was dosed in the Phase 1/2a
clinical trial of MP0533, a novel tetraspecific T cell engager for
the treatment of relapsed/refractory acute myeloid leukemia ("AML")
and myelodysplastic syndrome (MDS)/AML. Recruiting and
dose-escalation are ongoing with seven sites open across Europe,
presently dosing patients in the fourth cohort. Preliminary results
from this clinical trial are expected in Q4 2023 and additional
data in H1 2024.
The clonal heterogeneity and lack of single AML-specific target
antigens represent major challenges for the development of targeted
immune therapies for AML. Molecular Partners designed MP0533, a
tetraspecific CD3-engaging DARPin, which simultaneously targets
CD33, CD123 and CD70. This unique mode-of-action is designed to
enable avidity-driven T cell mediated killing of leukemic stem
cells and malignant blast cells, which co-express at least two of
the three target antigens, while preserving a therapeutic window
that minimizes damage to healthy cells.
MP0533's clinical development is supported by a comprehensive
preclinical data that was presented at the Annual Meeting of the
American Society of Hematology (ASH) in December 2022.
MP0317
In early June 2023, Molecular Partners presented additional
positive results from the ongoing Phase 1 clinical trial of MP0317,
a CD40 agonist designed to activate immune cells specifically
within the tumor microenvironment by anchoring to fibroblast
activation protein (FAP), which is highly expressed within tumors.
These data were presented at the American Society of Clinical
Oncology (ASCO) Annual Meeting 2023.
MP0317 is designed to resolve the historical limitations of
systemic CD40 agonists through the activation of the immune
stimulator CD40 only when simultaneously bound to FAP. This design
is intended to reduce systemic toxicities seen with prior CD40
agonists and focus CD40’s proven immuno-stimulatory properties on
tumor tissue.
Biomarker data of paired tumor biopsies confirmed that MP0317
achieved tumor-localized CD40 activation. The detection of MP0317
in tumors positively correlated with immune activation when
comparing high vs. low doses of MP0317, including a statistically
significant CD40-mediated increase of antigen-presenting cells and
interferon γ signature. MP0317 also demonstrated a favorable safety
profile when administered in 3-weekly (Q3W) and weekly (Q1W)
regimens, including the highest tested dose of 10mg/kg (Q3W).
Dosing at the highest planned regime (Q1W) is ongoing. Additional
data are expected to become available in H2 2023, with final data
from this Phase 1 clinical trial anticipated in H1 2024. Data
presented at ASCO 2023 build on the initial clinical data from the
program presented at the Society for Immunotherapy of Cancer (SITC)
annual meeting in November 2022 and support Molecular Partners’
strategy to pursue future combination studies of MP0317 with
potential partners.
Radio-DARPin Therapy ("RDT") platform
The Company's RDT platform is being developed to provide a
unique and innovative delivery system for radioactive payloads.
Thanks to their small size as well as their high specificity and
affinity, DARPins represent ideal vectors for efficient delivery of
therapeutic radionuclides to solid tumors while overcoming some
historic limitations of radioligand therapy approaches.
Notable recent achievements include a variety of preclinical
data supporting the ability to reduce kidney uptake of Radio-DARPin
conjugates to overcome nephrotoxicity, one of the key limitations
of small protein-based radiotherapies. Molecular Partners presented
positive preclinical data from its RDT platform in H1 2023 at the
12th International Symposium on Targeted Alpha Therapy (TAT 12), at
the Annual Meeting of the American Association for Cancer Research
(AACR), and at the Society of Nuclear Medicine & Molecular
Imagining (SNMMI). Additional work is ongoing to demonstrate the
ability of RDT to efficiently deliver high amounts of radioactivity
to the tumor, leading to effective tumor eradication. More details
on these efforts will be presented in the coming months and into
2024.
Molecular Partners continued to progress its RDT platform and
portfolio of projects, both in-house and in partnership with
Novartis. The tumor-associated protein Delta-like ligand 3 (DLL3)
has been selected as one of the first targets of Molecular
Partners’ proprietary RDT program.
Virology
As a furtherance of the clinical achievements with ensovibep for
COVID-19 in collaboration with Novartis, Molecular Partners and
Novartis signed a non-binding letter of intent in January 2023 to
negotiate a Research Framework Agreement with a primary focus on
emerging infectious global health threats.
Ophthalmology
Abicipar
In November 2021, Molecular Partners regained global development
and commercial rights to abicipar for the treatment of neovascular
age-related macular degeneration (nAMD) and Diabetic Macular Edema
(DME). Abicipar completed two positive Phase 3 clinical trials,
CEDAR and SEQUOIA, which supported the non-inferior efficacy of its
quarterly dosing regimen compared to monthly ranibizumab. The
Company continues to evaluate potential business opportunities for
abicipar outside of internal development at Molecular Partners.
Corporate and Management Highlights
On April 4, 2023, Molecular Partners shareholders approved all
motions proposed by the Board of Directors at the Annual General
meeting.
On August, 24, 2023, Nicolas Leupin, M.D. PhD notified Molecular
Partners AG of his intent to resign from Molecular Partners in his
capacity as Chief Medical Officer, for personal reasons. Dr. Leupin
joined Molecular Partners in 2019. Nicolas will remain with
Molecular Partners in an advisory capacity to assist with the
continued development of MP0533 and its clinical operations. Upon
this transition, Philippe Legenne, M.D., MBA, MHS, VP Medical
Strategy and Development, will take over activities from Nicolas
and serve as acting CMO.
Dr. Legenne joined Molecular Partners in early 2020. Over this
time, he has led the clinical development strategy and execution
across the Molecular Partners portfolio. Prior to joining Molecular
Partners, Philippe held positions of increasing responsibility at
JNJ, GSK, and Novartis, both in the United States and Europe. In
his most recent role prior to Molecular Partners, Philippe led the
EU medical organization for the oncology portfolio at Amgen. He
received his medical degree from the Université de Lille (France),
an MBA from ESSEC Business School (Paris) and a Master’s degree in
health economics from Université Paris Dauphine-PSL.
“I would like to thank Nicolas for his time and dedication to
Molecular Partners over the last four years. He has been
instrumental in building the clinical team we have today. I wish
him the best for his time off with his family and his future
endeavours,” said Patrick Amstutz, CEO of Molecular Partners. “I am
grateful that Phillipe is stepping into the role of acting CMO. He
has worked closely with Nicolas over the past years to establish
our key opinion leader network and initiate our clinical sites.
Phillipe and the team will continue our activities seamlessly with
MP0533, as well as the other DARPin programs moving towards
clinical development.”
ESG
In 2022, Molecular Partners published its environmental, social
and governance ("ESG") priorities and progress. Currently, the
Company is creating a baseline status evaluation as the next step
toward implementing an ESG plan with clear metrics that detail its
progress across priority areas: board oversight of ESG and
corporate sustainability; human capital management and Diversity,
Equity and Inclusion (DEI); product service and safety; access to
medicine; and business ethics.
In its continued commitment to corporate sustainability, MP is
continuously refining its ESG strategy to align with the expansion
of the pipeline, the future growth of the company and the values
and principles of its employees and shareholders. Elsewhere,
Molecular Partners offers generous benefits spanning from health to
retirement planning to its employees, and fosters diversity and
inclusion as a key element of its recruitment process.
H1 2023 Operational and Financial
Highlights
- Strong financial position with CHF 218.2 million in
cash (including short term deposits) as of June 30, 2023
- Net cash used in operating activities of
CHF 29.8 million in H1 2023
- Operating loss of CHF 31.0 million and net loss of
CHF 30.8 million in H1 2023
- Company expected to be funded well into 2026, excluding any
potential payments from R&D partnerships
The H1 2023 Financial Statements are available on the company's
website.
Key figures as of June
30, 2023 (unaudited) |
H1 2023 |
|
H1 2022 |
|
Change |
|
(CHF
million, except per share, FTE data) |
|
|
|
|
|
|
Total revenues and other income |
3.5 |
|
|
184.5 |
|
|
(181.0 |
) |
|
R&D expenses |
(24.3 |
) |
|
(27.0 |
) |
|
2.7 |
|
|
SG&A expenses |
(10.2 |
) |
|
(11.2 |
) |
|
1.0 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating
result |
(31.0 |
) |
|
146.3 |
|
|
(177.3 |
) |
|
Net
result |
(30.8 |
) |
|
148.6 |
|
|
(179.4 |
) |
|
Basic net result per share (in
CHF) |
(0.94 |
) |
|
4.59 |
|
|
(5.53 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash from (used
in) operating activities |
(29.8 |
) |
|
151.0 |
|
|
(180.8 |
) |
|
Cash balance (incl.
time deposits) as of June 30 |
218.2 |
|
|
285.1 |
|
|
(66.9 |
) |
|
Total shareholders’
equity as of June 30 |
206.0 |
|
|
265.9 |
|
|
(59.9 |
) |
|
Number of total FTE as
of June 30 |
168.5 |
|
|
164.0 |
|
|
4.5 |
|
|
|
Business Outlook and Priorities
Molecular Partners’ strategic focus on areas of maximum
differentiation by virtue of DARPins' unique capabilities remains
steady, with funding to support portfolio development forecasted
well into 2026. With two existing clinical programs and new areas
of growth in the Radio DARPin Therapy and antiviral portfolios,
Molecular Partners is well positioned to generate value through
developmental milestones, new candidates and potential
partnerships.
Financial Outlook 2023
For 2023, at constant exchange rates, the Company expects total
expenses of CHF 65 - 75 million (previously estimated at CHF 70 -
80 million), of which approximately CHF 9.0 million will
be non-cash effective costs for share-based payments, IFRS pension
accounting and depreciation. This guidance does not include any
potential receipts from R&D partnerships.
With CHF 218.2 million in cash and short-term time
deposits and no debt as of June 30, 2023, the Company expects
to be funded well into 2026, excluding any potential receipts from
R&D partners.
The Company's balance sheet continued to be debt-free in 2023.
As of June 30, 2023, the Company employed 168.5 FTE (full time
equivalents), up 3% year-on-year. About 84% of the employees are
employed in R&D-related functions.
Documentation
The results presentation, this press release, and the H1 2023
report will be made available on www.molecularpartners.com after
10:00pm (CET) on August 24, 2023.
H1 2023 Conference Call & Audio Webcast
Molecular Partners will hold a conference call and audio webcast
on August 25, 2023, 2:00pm CET (8:00am EDT). To register for the H1
2023 conference call, please dial the following numbers
approximately 10 minutes before the start of the presentation:
Switzerland / Europe: |
+41 43 210 5163 |
USA: |
+1 800 715 9871 |
UK: |
+44 800 260 6466 |
Conference ID: |
8671406 |
Financial calendar
August 24, 2023 |
Half-year results 2023 (unaudited) |
October 26, 2023 |
Interim Management Statement Q3 2023 |
The latest timing of the above events can always be viewed on
the investor section of the website.
About DARPin Therapeutics
DARPin therapeutics are a new class of custom-built protein
therapeutics based on natural binding proteins that open a new
dimension of multi-functionality and multi-target specificity in
drug design. A single DARPin candidate can engage more than five
targets, and its flexible architecture and small size offer
benefits over other currently available protein therapeutics.
DARPin therapeutics have been clinically validated through to
registration via the development of abicipar, Molecular Partners’
most advanced DARPin drug candidate. The DARPin platform is a fast
and cost-effective drug discovery engine, producing drug candidates
with optimized properties for development and very high production
yields.
About Molecular Partners AG
Molecular Partners AG is a clinical-stage biotech company
developing DARPin (designed ankyrin repeat
protein) therapeutics, a new class of custom-built protein
drugs designed to address challenges current modalities cannot. The
Company has formed partnerships with leading pharmaceutical
companies to advance DARPin therapeutics in the areas of
oncology and virology and has compounds in various stages of
clinical and preclinical development across multiple therapeutic
areas. www.molecularpartners.com; Find us on Twitter
- @MolecularPrtnrs
Cautionary Note Regarding Forward-Looking
Statements Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995, as amended, including,
without limitation, implied and express statements regarding the
clinical development of Molecular Partners’ current or future
product candidates, expectations regarding timing for reporting
data from ongoing clinical trials or the initiation of future
clinical trials, the potential therapeutic and clinical benefits of
Molecular Partners’ product candidates, the selection and
development of future antiviral or other programs, and Molecular
Partners’ expected business and financial outlook, including
expenses and cash utilization for 2023 and its expectation of its
current cash runway. These statements may be identified by words
such as “believe”, “expect”, “may”, “plan”, “potential”, “will”,
“would” and similar expressions, and are based on Molecular
Partners’ current beliefs and expectations. These statements
involve risks and uncertainties that could cause actual results to
differ materially from those reflected in such statements. Some of
the key factors that could cause actual results to differ from
Molecular Partners’ expectations include its plans to develop and
potentially commercialize its product candidates; Molecular
Partners’ reliance on third party partners and collaborators over
which it may not always have full control; Molecular Partners’
ongoing and planned clinical trials and preclinical studies for its
product candidates, including the timing of such trials and
studies; the risk that the results of preclinical studies and
clinical trials may not be predictive of future results in
connection with future clinical trials; the timing of and Molecular
Partners’ ability to obtain and maintain regulatory approvals for
its product candidates; the extent of clinical trials potentially
required for Molecular Partners’ product candidates; the clinical
utility and ability to achieve market acceptance of Molecular
Partners’ product candidates; the impact of any health pandemic,
macroeconomic factors and other global events on Molecular
Partners’ preclinical studies, clinical trials or operations, or
the operations of third parties on which it relies; Molecular
Partners’ plans and development of any new indications for its
product candidates; Molecular Partners’ commercialization,
marketing and manufacturing capabilities and strategy; Molecular
Partners’ intellectual property position; Molecular Partners’
ability to identify and in-license additional product candidates;
and other risks and uncertainties that are described in the Risk
Factors section of Molecular Partners’ Annual Report on Form 20-F
for the fiscal year ended December 31, 2022, filed with Securities
and Exchange Commission (SEC) on March 9, 2023 and other filings
Molecular Partners makes with the SEC. These documents are
available on the Investors page of Molecular Partners’ website at
www.molecularpartners.com. Any forward-looking statements speak
only as of the date of this press release and are based on
information available to Molecular Partners as of the date of this
release, and Molecular Partners assumes no obligation to, and does
not intend to, update any forward-looking statements, whether as a
result of new information, future events or otherwise.
For further details, please contact:Seth Lewis,
Head of Investor Relations & StrategyConcord, Massachusetts,
U.S.seth.lewis@molecularpartners.comTel: +1 781 420 2361
Antonio Ligi, Head of CommunicationsZurich-Schlieren,
Switzerlandantonio.ligi@molecularpartners.comTel: +41 44 755 57
53
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